Pain After Cardiac Arrest and Resuscitation (PAINCARE)

NCT07564778 | Recruiting

• 1 other identifier: STEPCARE_PAINCARE
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

The PAINCARE substudy is an observational cohort substudy nested within the international STEPCARE trial, which evaluates sedation, temperature, and mean arterial pressure strategies after out-of-hospital cardiac arrest. PAINCARE aims to describe the burden of pain during early intensive care after cardiac arrest and to evaluate associations between early pain burden and selected ICU and patient-reported outcomes. Pain is common in critically ill patients but may be difficult to assess in patients who are unconscious, sedated, mechanically ventilated, or unable to self-report. PAINCARE collects structured pain assessments during the first 168 hours after randomization using validated self-report or behavioral pain instruments and relates early pain burden to outcomes including delirium burden, ventilator-free time, ICU-free time, and follow-up pain outcomes. All analyses are observational; PAINCARE is not designed to determine whether modifying pain burden improves outcomes.

Conditions

Out-of-hospital Cardiac Arrest (OHCA); Pain

Keywords

Chest compressions; delirium; quality of life; Cardiopulmonary resuscitation; Mechanical ventilation; ICU length of stay; critical care; cardiac arrest survivors; pain assessment

Outcome Measures

Primary Outcomes (1)

• Cumulative Time in Moderate or Severe Pain While Alive and in the ICU Through 168 Hours

  Cumulative time, in hours, spent in moderate or severe pain while alive and in the ICU from randomization through 168 hours, ICU discharge, or death, whichever occurs first. Moderate or severe pain is defined as NRS \>3, CPOT \>2, or BPS \>5. Each scheduled assessment represents the worst pain intensity since the previous assessment and is assigned to the corresponding preceding interval.

  From randomization through 168 hours, ICU discharge, or death, whichever occurs first

Secondary Outcomes (5)

• Proportion of Evaluable Alive-in-ICU Time Spent in Moderate or Severe Pain Through 168 Hours

  From randomization through 168 hours, ICU discharge, or death, whichever occurs first

• Delirium Burden Through 168 Hours

  From randomization through 168 hours

• Hours Alive and Free of Invasive Ventilatory Support Through Day 30

  From randomization through day 30

• ICU-Free Days Alive Through Day 30

  From randomization through day 30

• Moderate or Severe Pain at 1 Month

  At 1 month

Other Outcomes (3)

• Moderate or Severe Pain at 6 Months

  At 6 months

• Health-Related Quality of Life at 6 Months

  At 6 months

• Mobilization During ICU Care

  From randomization through 168 hours

Study Arms (1)

Comatose out-of-hospital cardiac arrest patients

Adult participants in the STEPCARE trial (NCT05564754) enrolled at PAINCARE-participating sites under approved PAINCARE substudy procedures and not withdrawn from use of study data according to parent-trial procedures. PAINCARE inclusion may occur retrospectively or prospectively according to local approvals and substudy implementation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

STEPCARE participants at PAINCARE-participating sites who are included under approved PAINCARE substudy procedures and have not withdrawn consent for use of study data according to parent-trial procedures. PAINCARE participants may be included retrospectively or prospectively according to local approvals and substudy implementation.

You may qualify if:

• Out-of-hospital cardiac arrest
• Adult, age 18 years or older
• Spontaneous circulation without chest compressions for at least 20 minutes
• Comatose, defined as not obeying verbal commands
• Enrolled within 4 hours after return of spontaneous circulation

You may not qualify if:

• Restrictions or limitations of care
• On extracorporeal membrane oxygenation before randomization
• Pregnancy
• Previously randomized in the STEPCARE trial
• Trauma or hemorrhage as the presumed cause of arrest
• Suspected or confirmed intracranial hemorrhage

Sponsors & Collaborators

• Region Skane: lead

Study Sites (3)

Dep. of Intensive Care Halmstad Lasarett

Halmstad, Sweden

RECRUITING

Department of Intensive Care, Skåne University Hospital

Malmö, 20205, Sweden

RECRUITING

Dep. of Intensive Care, Norrlands Universitets Sjukhus

Umeå, Sweden

RECRUITING

Related Publications (3)

• Niemela VH, Reinikainen M, Nielsen N, Bass F, Young P, Lilja G, Dankiewicz J, Hammond N, Hastbacka J, Levin H, Moseby-Knappe M, Saxena M, Tiainen M, Ceric A, Holgersson J, Kamp CB, Tirkkonen J, Oksanen T, Kaakinen T, Bendel S, During J, Lybeck A, Johnsson J, Unden J, Lundin A, Kahlin J, Grip J, Lotman E, Romundstad L, Seidel P, Stammet P, Graf T, Mengel A, Leithner C, Nee J, Druwe P, Ameloot K, Wise MP, McGuigan PJ, White J, Govier M, Maccaroni M, Ostermann M, Hopkins P, Proudfoot A, Handslip R, Pogson D, Jackson P, Nichol A, Haenggi M, Hilty MP, Iten M, Schrag C, Nafi M, Joannidis M, Robba C, Pellis T, Belohlavek J, Rob D, Arabi Y, Buabbas S, Yew Woon C, Aneman A, Stewart A, Arnott C, Ramanan M, Panwar R, Delaney A, Reade M, Venkatesh B, Navarra L, Crichton B, Knight D, Williams A, Friberg H, Cronberg T, Jakobsen JC, Skrifvars MB. Higher versus lower mean arterial blood pressure after cardiac arrest and resuscitation (MAP-CARE): A protocol for a randomized clinical trial. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70040. doi: 10.1111/aas.70040.

  PMID: 40392139 RESULT

• Holgersson J, Niemela V, Skrifvars MB, Kamp-Jorgensen C, Saxena M, Young P, Bass F, Dankiewicz J, Hammond N, Hastbacka J, Levin H, Lilja G, Moseby-Knappe M, Tiainen M, Reinikainen M, Ceric A, During J, Lybeck A, Rodriguez-Santos D, Johnsson J, Unden J, Lundin A, Kahlin J, Grip J, Rosell J, Lotman EM, Navarra L, Crichton B, Knight D, Williams A, Romundstad L, Seidel P, Stammet P, Graf T, Mengel A, Leithner C, Nee J, Druwe P, Ameloot K, Wise M, Riddel J, Ahmed M, Buckel M, Mc Guigan P, Maharaj R, Wyncoll D, Thomas M, White J, Keeble TR, Pogson D, Nichol A, Haenggi M, Hilty MP, Iten M, Schrag C, Nafi M, Joannidis M, Robba C, Pellis T, Belohlavek J, Smid O, Rob D, Arabi Y, Buabbas S, Yew Woon C, Aneman A, Stewart A, Bernard S, Palmer-Simpson C, Simpson N, Ramanan M, Reade M, Delaney A, Venkatesh B, Tirkkonen J, Oksanen T, Kaakinen T, Bendel S, Friberg H, Cronberg T, Jakobsen J, Nielsen N. Fever management with or without a temperature control device after out-of-hospital cardiac arrest and resuscitation (TEMP-CARE): A study protocol for a randomized clinical trial. Acta Anaesthesiol Scand. 2025 May;69(5):e70034. doi: 10.1111/aas.70034.

  PMID: 40222389 RESULT

• Ceric A, Dankiewicz J, Hastbacka J, Young P, Niemela VH, Bass F, Skrifvars MB, Hammond N, Saxena M, Levin H, Lilja G, Moseby-Knappe M, Tiainen M, Reinikainen M, Holgersson J, Kamp CB, Wise MP, McGuigan PJ, White J, Sweet K, Keeble TR, Glover G, Hopkins P, Remmington C, Cole JM, Gorgoraptis N, Pogson DG, Jackson P, During J, Lybeck A, Johnsson J, Unden J, Lundin A, Kahlin J, Grip J, Lotman EM, Romundstad L, Seidel P, Stammet P, Graf T, Mengel A, Leithner C, Nee J, Druwe P, Ameloot K, Nichol A, Haenggi M, Hilty MP, Iten M, Schrag C, Nafi M, Joannidis M, Robba C, Pellis T, Belohlavek J, Rob D, Arabi YM, Buabbas S, Yew Woon C, Aneman A, Stewart A, Reade M, Delcourt C, Delaney A, Ramanan M, Venkatesh B, Navarra L, Crichton B, Williams A, Knight D, Tirkkonen J, Oksanen T, Kaakinen T, Bendel S, Friberg H, Cronberg T, Jakobsen JC, Nielsen N. Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED-CARE): A protocol for a randomized clinical trial. Acta Anaesthesiol Scand. 2025 May;69(5):e70022. doi: 10.1111/aas.70022.

  PMID: 40178107 RESULT

MeSH Terms

Conditions

Pain; Out-of-Hospital Cardiac Arrest; Delirium

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Arrest; Heart Diseases; Cardiovascular Diseases; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Joachim P Düring, MD, PhD

  Lunds Universitet, Institutionen för kliniska vetenskaper, Lund, Anesthesia and Intensive Care, Skåne University Hospital , Malmö, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joachim P Düring, MD, PhD

CONTACT

+46705917599; joachim.during@med.lu.se

Mia H Hylén, RN, PhD

CONTACT

+46708277226; mia.hylen@skane.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: October 15, 2023
• Primary Completion: May 19, 2026
• Study Completion (Estimated): October 31, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)